42 C.F.R. § 424.34

Additional requirements: Beneficiary's claim for direct payment

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(a) Basic rule. A beneficiary's claim for direct payment for services furnished by a supplier, or by a nonparticipating hospital that has not elected to claim payment for emergency services, must include an itemized bill or a “report of services”, as specified in paragraphs (b) and (c) of this section.

(b) Itemized bill from the hospital or supplier. The itemized bill for the services, which may be receipted or unpaid, must include all of the following information:

(1) The name and address of—

(i) The beneficiary;

(ii) The supplier or nonparticipating hospital that furnished the services; and

(iii) The physician who prescribed the services if they were furnished by a supplier other than the physician.

(2) The place where each service was furnished, e.g., home, office, independent laboratory, hospital.

(3) The date each service was furnished.

(4) A listing of the services in sufficient detail to permit determination of payment under the fee schedule for physicians' services; for itemized bills from physicians, appropriate diagnostic coding using ICD-9-CM must be used.

(5) The charges for each service.

(c) Report of services furnished by a supplier. For Medicare Part B services furnished by a supplier, the beneficiary claims may include the “Report of Services” portion of the appropriate claims form, completed by the supplier in accordance with CMS instructions, in lieu of an itemized bill.

[53 FR 6634, Mar. 2, 1988, as amended at 59 FR 10299, Mar. 4, 1994; 59 FR 26740, May 24, 1994]
Notes of Decisions
Cited in 2 cases (1 in the last 5 years), 2005–2025 · leading case: Connecticut Dep't of Soc. Servs. v. Leavitt, 428 F.3d 138 (2d Cir. 2005).
Connecticut Dep't of Soc. Servs. v. Leavitt, 428 F.3d 138 (2d Cir. 2005). · cites it 2× “Indeed, the regulation that governs direct claims by beneficiaries, 42 C.F.R. § 424.34 , refers only to “[a] beneficiary’s claim for direct payment for services furnished by a supplier [defined to exclude providers such as home healthcare agencies, see id.”
Carlin (S.D.N.Y. 2025). “See 42 C.F.R. § 424.34 . In either case, if a Medicare beneficiary is dissatisfied with a MAC’s initial determination, the beneficiary must pursue a multi-level administrative appeals process before seeking judicial review.”
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